Sepha, the Northern Ireland-based pharmaceutical packaging and equipment company, has developed a new compact small-batch blister packaging system with extensive traceability and electronic data storage capabilities. The EZ Blister+ has been working on increasing demand for 21 CFR Part 11 compliant micro-batches throughout the blister production cycle, from R&D till commercial production.
The EZ+ Blister responds to calls from larger pharmaceutical companies and Contract Manufacturing Organizations (CMOs) for a small-scale blister packaging machine with 21 CFR Part 11 capabilities. In recent years, demand for small quantities of pharmaceuticals and medical devices has exploded, and these businesses are struggling to handle frequent requests for high-speed blister lines.
Manufacturers have traditionally relied on lab-scale blister packaging machines to produce small quantities of drugs and medical devices for research or clinical trials. However, most bench-top machines are not intended for commercial production, although they are capable of accomplishing small orders, and are lacking the necessary software architecture to demonstrate compliance with 21 CFR Part 11. Therefore, manufacturers are left without the need to use their high-speed lines, which cannot be justified in terms of line clearance and change periods.
The EZ Blister+, which developed after 12 months of research, is capable of reducing this gap by providing a 21 CFR Part 11-ready system for producing small batches with electronic signatures and documentation. The machine, which developed the same proven blister packaging capability, has expanded to include software capabilities that facilitate the creation of electronic signatures and batch reports. The EZ Blister+ is a combination of approaches, including from recipe creation and management to reporting.
According to Paul Smith, the Managing Director of Sepha, pharmaceutical manufacturers desire electronic record keeping, and digital connectivity from all of their packaging equipment, not just their high-speed lines. They are also looking to develop digital eco-systems in which all systems are connected and centrally controlled, thus that when the auditors knocking, they can easily demonstrate compliance. Despite this, the trend towards small batches is also growing in the EZ Blister+, which we believe to be the first micro-batch blister packaging machine to offer 21
We have upgraded the EZ Blister device to a highly intelligent processor that can record all data necessary for traceability and connect with a company network, which allows site personnel to have full visibility.
The EZ Blister+ employs proven forming, sealing, and cutting techniques to ensure packets are of the same quality and integrity as those used on large blister packaging lines. Blister trays or cards are thermoformed or coldformed according to the exact specifications of the product, sealed with pre-cut pieces of lidding material, then cut and perforated using a precision die-cutter. Tablets, capsules, ampoules, and other products can all be packaged on this compact, versatile system.